试验五维生素C注射液处方设计与制备.DOC

实验五. 维生素C注射液处方设计与制备 Zhaozhiguang 0641618 【摘要】 目的：1、掌握维生素C的注射剂的制备方法及工艺过程的操作要点。 2、熟悉注射剂成品质量检查标准和检查方法，了解影响成品质量的因素。 3、熟悉提高易氧化药物稳定性的基本方法。 4、了解无菌与灭菌制剂生产工艺中的关键操作。 方法：采用稀配法配置;垂熔玻璃滤器过滤;手工熔封。 结果：得到维生素C注射剂15支。 结论：在处方设计中考虑以下措施延缓药物氧化分解：除氧；加抗氧剂；调节溶液pH在最稳定的pH范围内；加金属离子络合剂。 【关键词】 维生素C注射剂，稀配法，易氧化药物稳定性。 Exp 5. Formulation Design and Preparation of Vitamin C Injections Lishuo(0641625) 【Abstract】 Aim: 1. To master the key points to prepare Vitmin C injections and the related manufactureing process. 2. To be familiar with the standard and methods of quality control of the end injection, to understand the factors influencing on quality of end products. 3. To be familiar with the means to enhance the stability of oxidable drugs. 4. To understand the key points in the manufacturing process of sterile preparation. Methods: Preparate with dilution method;filtrate with sintered glass funnel;seal the ampoules in flame. Results: Get 15 pieces of Vitamin C Injections. Conclusion: The formulation design for ascorbic acid injection need to be primarily plotted to prevent the oxidation of ascorbic acid. Several measures have be taken as follows: depletion of O2; addition of antioxidants; adjustment ment of pH in the range where ascorbic acid is most stable;addition of EDTA to reduce the influence of heaven metal ions such as Cu2+. 【Key words】Vitamin C Injections, dilution method, the stability of oxidable drugs. 【Fordword】 Injections are sterile products containing medicaments intended for parenteral administration into the body, including solutions, emulsions, suspensions as well as sterile powers or concentrate solutions, which , by the addition of suitable solvents before use, form solutions or suspension. The production of injection must follow rigid aseptic procedures. In the preparation of parenteral solutions, the required ingredients are dissolved in water